BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPS ORTHOLOC LATERAL LEFT PLATE

    MDR report key: 24365418 · Received February 17, 2026

    Report

    Report Number
    0008031020-2026-00174
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    January 18, 2026
    Report Date
    May 18, 2026
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HRS
    UDI-DI
    00840420125798
    PMA / PMN Number
    K100146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE PATIENT UNDERWENT A LEFT RADIAL HEAD REPLACEMENT FOR FRACTURE, APPROX. 2 AND HALF YEARS AGO, USING THE TORNIER MOPYC SYSTEM. PATIENT HAD PRESENTED TO THE SURGEON WITH PAIN, OVER LAST 4-6 MONTHS. ON X-RAY, IT SHOWED THE PROSTHETIC PYROCARBON HEAD RUBBING AGAINST A DISTAL HUMERAL PLATE, ALSO INSITU (IMPLANTED FOR AN ASSOCIATED FRACTURE OF THE DISTAL HUMERUS). DURING SURGERY, LARGE AMOUNTS OF BLACK COLOURED TISSUE WERE NOTED, AND AN EXTENSIVE DEBRIDEMENT AND LAVAGE WAS PERFORMED. MULTIPLE TISSUE SAMPLES TAKEN. THE ORIGINAL MOPYC STEM WAS FOUND TO BE SOLID AND THEREFORE LEFT INSITU. THE PRIMARY MOPYC NECK AND HEAD WAS REMOVED (WITHOUT DIFFICULTY) AND REPLACED WITH NEW PROSTHESIS. THE DISTAL HUMERAL PLATE, WHICH WAS RUBBING AGAINST THE PYC HEAD, WAS ALSO REMOVED (THE DISTAL HUMERAL FRACTURE WAS UNITED). THE ELBOW JOINT WAS FOUND TO BE STABLE ON REDUCTION. WOUND CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387076 EPS ORTHOLOC LATERAL LEFT PLATE PLATE, FIXATION, BONE HRS WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN 00840420125798

    Patients

    Seq Age Sex Outcome Treatment
    1